Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000551998
Ethics application status
Approved
Date submitted
28/05/2011
Date registered
31/05/2011
Date last updated
7/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of regular back movements in preventing children from getting back pain
Scientific title
A randomized controlled trial to investigate the effect of regular specific movement of the pelvis and lumbar spine on the incidence of low back pain in children aged 8-11 years.
Secondary ID [1] 262244 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain in children 267941 0
Condition category
Condition code
Musculoskeletal 268081 268081 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The effect of a spinal movement program taught to children in schools and repeated daily at home. The children are taught 4 simple spinal exercises that are completed in standing and take approximately 2 minutes. Additionally the children are given information about back care. The children are taught the exercises in school on day 0 of the study. Baseline data about previous and current low back pian episodes are collected from children at day 0. The children subsequently receive 6 school visits each lasting 15 minutes over the following 10 months. The exercises are reviewed at each visit to encourage the children to do the exercises in a standardised way. They are encouraged to repeat them daily at home preferably while cleaning their teeth. Following each visit (within 10 days of the visit), the children complete an on-line survey to report low back pain episodes and exercise adherence.
Intervention code [1] 266641 0
Prevention
Intervention code [2] 266669 0
Behaviour
Comparator / control treatment
No exercise (standard back information). The interventions in the control group are the same in every way to the intervention group except that children are not taught the spinal exercise program.
The control group receive an initial visit at day 0 to obtain baseline data and additionally the children are given information about back care. The children receive 6 school visits over the following 10 months where the back information is reviewed. Following each visit (within 10 days of the visit), the children complete an on-line survey to monitor any low back pain episodes.
Control group
Active

Outcomes
Primary outcome [1] 266819 0
Episode of low back pain.
Low back pain is defined as activity limiting pain lasting more than one day in the area on the posterior aspect of the body from the bottom of the 12th rib to the lower gluteal folds. A diagram will be supplied to all participants showing this specific area.
Participants are monitored for any low back pain in the previous week in the area defined, plus one or more of the following
1. Pain lasting more than one day 2.Required the participant to stay off school. 3.Required the participant to stop school sports. 4. Required a visit to a doctor or other medical person, (physiotherapist, nurse /chiropractor /osteopath/other)

Survey:
The participants are asked the following questions at each of the 6 surveys following commencement of the intervention:

1. Have you had back pain in the area shaded in the picture in the LAST WEEK?

2. How many days did it last? 1 2 3 4 5 6 7 more than 7


3. Did you stay off school because of this back pain?

4. Did you stop school sports because of this back pain?

5. Did you see a health professional such as a doctor, physiotherapist, nurse, chiropractor, or osteopath because of this back pain?

6 Did you do the MYSPINE EXERCISES this week?
Every day. Every second day. About twice. About once. Not at all

7. The reasons I sometimes did not do my exercises:
Sickness/injury. Forgot. Can't remember how to do the movements. Find the movements uncomfortable. Too busy
Timepoint [1] 266819 0
Back pain data is collected at day 7, day 21, day 49, day 105, day 161 and day 270
Secondary outcome [1] 276501 0
Nil
Timepoint [1] 276501 0
Nil

Eligibility
Key inclusion criteria
Consenting children aged 8 to 11 years who attend a primary school in the North Shore region of Auckland, New Zealand. Children are included if they can follow simple instructions and complete a child friendly survey, and whose parents approve their participation.
Minimum age
8 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children who are not able to do the exercises due to spinal pathologies and/or neurological disorders, injuries or physical disabilities that prevent the child from standing on one leg safely and independently.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Several schools were chosen from a database of primary schools in the North Shore region, Auckland North, New Zealand. They were chosen from a convenient geographical area. Randomisation was undertaken using computer generated random number tables. Each participating school was allocated a number. Schools were randomly assigned by a blinded researcher into Group 1 (no intervention control) or Group 2 (spinal movement group).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Schools were randomised by an off site researcher. A list of deidentified schools and the numbers in each group were randomised by an off site researcher after stratification for student numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster (schools)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2011
Actual
1/04/2011
Date of last participant enrolment
Anticipated
11/04/2011
Actual
11/04/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment outside Australia
Country [1] 3600 0
New Zealand
State/province [1] 3600 0
Auckland

Funding & Sponsors
Funding source category [1] 267126 0
Self funded/Unfunded
Name [1] 267126 0
Julia Hill
Country [1] 267126 0
New Zealand
Primary sponsor type
Individual
Name
Julia Hill
Address
5 Empire Road
Devonport
Auckland 0624
Country
New Zealand
Secondary sponsor category [1] 264204 0
None
Name [1] 264204 0
Address [1] 264204 0
Country [1] 264204 0
Other collaborator category [1] 252016 0
University
Name [1] 252016 0
Professor Jenny Keating
Address [1] 252016 0
School of Primary Health Care
Monash University
Peninsula Campus,
PO Box 527,
Frankston, Victoria, 3199
Country [1] 252016 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267109 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 267109 0
Ethics committee country [1] 267109 0
New Zealand
Date submitted for ethics approval [1] 267109 0
Approval date [1] 267109 0
16/02/2011
Ethics approval number [1] 267109 0
NTY/10/11/093
Ethics committee name [2] 267110 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [2] 267110 0
Ethics committee country [2] 267110 0
Australia
Date submitted for ethics approval [2] 267110 0
Approval date [2] 267110 0
02/03/2011
Ethics approval number [2] 267110 0
2011000216

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32647 0
Ms Julia Hill
Address 32647 0
Principles organisation is:
Department of Physiotherapy
School of Primary Health Care
Faculty of Medicine Nursing and Health Science
Monash University
PO Box 527 Frankston,
Victoria, 3199 Australia
Postal address in New Zealand:
5 Empire Road
Devonport
Auckland 0624
New Zealand
Country 32647 0
New Zealand
Phone 32647 0
64211299936
Fax 32647 0
Email 32647 0
[email protected]
Contact person for public queries
Name 15894 0
Julia Hill
Address 15894 0
5 Empire Road
Devonport
Auckland
0624
Country 15894 0
New Zealand
Phone 15894 0
00 64 9 4459311
Fax 15894 0
Email 15894 0
[email protected]
Contact person for scientific queries
Name 6822 0
Julia Hill
Address 6822 0
5 Empire Road
Devonport
Auckland
0624
Country 6822 0
New Zealand
Phone 6822 0
00 64 9 4459311
Fax 6822 0
Email 6822 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDaily exercises and education for preventing low back pain in children: cluster randomized controlled trial.2015https://dx.doi.org/10.2522/ptj.20140273
EmbaseEncouraging healthy spine habits to prevent low back pain in children: an observational study of adherence to exercise.2016https://dx.doi.org/10.1016/j.physio.2015.05.005
N.B. These documents automatically identified may not have been verified by the study sponsor.